As an engineering intern at a biomedical equipment manufacturer, I have had the opportunity to perform tasks within the quality assurance and compliance realm, such as modifying SOPs that adhere to ISO18485 and GMP. I tend to have a strong…   Read more»

Working with a diverse team, whose members come from varying backgrounds and perspectives, is essential for any project. As a director of a diverse team, I would greatly appreciate these differences and encourage my team to maintain open-mindedness in decision-making…   Read more»

Although both major functions, product development and post-market management, have their own unique impacts on a project as a whole, I consider product development the more significant of the two. The uncertainty and approval surrounding the product development process makes…   Read more»

If I were to have the option to conduct research in academia or industry, I would choose academia. When researching in academia, you are given almost a free range of possibilities to peruse what interests you most. You are able…   Read more»

Generalizing professors and their interests is unjust, so it is safe to say that the answer to this question varies based on the professor, which we have all experienced first-hand as students. Some professors are solely concerned about their research…   Read more»

The Institutional Animal Care and Use Committees (IACUCs) exists to achieve the balance between necessary, safe animal testing and maintaining animal welfare, minimizing the use of animals in pre-clinical trials when possible. Although the IACUCs have federally required guidelines that…   Read more»

The balance between thorough detail and flexibility are important in project planning. Too much detail, such as consistent step-by-step can be a burden for team members when attempting to achieve meaningful work and providing their own unique skill sets and…   Read more»

A project should no longer be considered feasible once a team has reached a “dead end” countless times and spent a noteworthy amount of budget in the persuit of the project. The team has also analyzed the possibilities of if…   Read more»

Project managers must first identify clear parameters as to what must be accomplished. This includes constructing a Gantt chart with strict deadlines and incorporated slack time for potential delays. All tasks should be further broken down into more specific tasks…   Read more»

To evaluate how to develop a project team, it is important to identify the areas that the team can build upon and improve. With these areas in mind, human resource management can create team building activities, trainings, etc. that address…   Read more»

Quality control is sometimes lacking in smaller organizations due to the nature of smaller organizations/projects commonly being relatively new. With limited experience in their field and awareness of the benefits of quality management, smaller, newer project members can tend to…   Read more»

Quality management is not common to find in smaller companies due to the nature of smaller companies commonly being relatively new. With limited experience in their field and awareness of the benefits of quality management, smaller, newer companies can tend…   Read more»

An example of a medical device in development that would likely not require validation is a simple adhesive bandage. As mentioned in the prompt, verification testing would be enough in the case of this product. The verification testing would serve…   Read more»

I believe that the project planning phase is most important. With poor planning, clear objectives aren’t outlined and communicated, causing confusion among a project team of what is expected of them. The planning phase is critical in identifying risks, thereby…   Read more»

There are many aspects of medical device projects that require tedious monitoring and controlling across several areas. Stakeholder communication is an example. Ensuring efficient communication with stakeholders, clients, and internal staff is vital for the project’s success. Supervising and regulating…   Read more»

I believe that Stryker should not be neglecting the foot&ankle team just because it is considered a low-priority project. Styker needs to decide if a.) the foot&ankle project is so low-priority that it should be scrapped entirely and the team…   Read more»

Before beginning a project as a team, it is important that the team delegates tasks and assigns responsibilities to each individual teammate based on his/her strengths. To establish early on what will be expected of each team member throughout the…   Read more»

A challenge faced by project managers is risk management. Every project comes with its set of risks, which can range from unforeseen technical difficulties, changes in market conditions, to delays in deliverables from third parties. These risks can significantly impact…   Read more»

The most difficult part of a project for me often revolves around maintaining momentum and addressing any unforeseen challenges that have emerged. One of the key challenges is ensuring that the project remains on schedule. Delays can occur due to…   Read more»

Ensuring that I provide the most complete and robust solutions to my team, even with limited time and contextual information, involves a multifaceted approach. First, I would prioritize establishing strong communication channels within the team and management. This ensures that…   Read more»